Novartis expands its oncology pipeline by entering into a license agreement with BeiGene for rights to market tislelizumab in major markets outside of China. Tislelizumab is a novel humanized anti–PD-1 monoclonal antibody, specifically designed to block binding of FcγR on macrophages and trigger the activation of antibody-dependent macrophage-mediated killing of T effector cells. Currently marketed PD-1 inhibitors Keytruda and Opdivo have emerged as blockbusters in their categories.
Under the terms of the agreement, Novartis receives development and commercialization rights to tislelizumab in the USA, Mexico, Canada, the United Kingdom, EU, Switzerland, Russia, Norway, Iceland, Liechtenstein and Japan for an upfront payment of USD 650 million along with royalties and milestone payments. BeiGene holds the rights for China and other markets not covered under the license agreement.
Tislelizumab has already been approved by the China National Medical Products Administration (NMPA) for the following indications – classical Hodgkin’s lymphoma and metastatic urothelial carcinoma and BeiGene has filed other supplemental applications expanding the use in other cancer types. The First ex-China regulatory filing is expected in 2021. Novartis and BeiGene have further identified development opportunities in solid tumors with a combination of Tislelizumab and other oncology therapies by Novartis. Novartis earlier had a PD-1 therapy spartalizumab, in its pipeline which failed in its phase 3 trial when used in combination with Tafinlar and Mekinist as the combination therapy did not have any statistically significant impact on the outcome of therapy whether the duo was used with or without spartalizumab.
Current anti-PD-1 therapies have transformed the existing standard-of-care in many different types of cancer and they further have the potential to be used as combination therapies with other oncology drugs. While Novartis made its entry late into the game and competition may be stiff with current Merck and BMS therapies, the in-licensed late-stage therapy from BeiGene may in accelerating its oncology portfolio by participating in the rapidly growing PD-1 inhibitor market both as a monotherapy and paired with its own portfolio of cancer drugs as a combination therapy. The late-stage asset partnership re-emphasises that in the biologics industry, timing is of critical essence and strategic partnerships are the way to go to bring together complementary strengths in drug development and commercialization.